During the 2019 ISPE Meeting & Expo (27–30 October, Las Vegas, Nevada), Lonza and Nephron Pharmaceuticals Corporation will co-present the results of the first implementation of Lonza’s MODA-ES™ Platform, a next-generation electronic batch record (EBR) solution for the pharmaceutical manufacturing industry. Lonza partnered with Nephron, a global leader in the manufacture of generic respiratory medications, to implement the MODA-ES™ Platform, overcoming a number of implementation hurdles and completing the process in an accelerated nine-month timeframe. The successful implementation of the platform has delivered significant operational efficiency gains at Nephron, improving the quality of batch record data and enabling the rapid expansion of its product line without increasing company headcount. Lonza and Nephron will present detailed results of the collaboration on Sunday, October 27 from 13:00–15:00 as part of the Information Systems Track at the ISPE 2019 annual meeting.
© Lonza, Basel
The transition to an Electronic Batch Record has immediate advantages over paper-based documentation, eliminating human error, increasing efficiency and expediting product time-to-market. These benefits are particularly important for pharmaceutical manufacturers wanting to expand their production to meet the rapidly growing global demand for pharmaceutical products. However, such solutions have previously been out of reach for many on account of their prohibitive costs and the great complexity of the implementation process.
Lonza’s MODA-ES™ Platform has been specifically developed to offer a flexible and cost-effective EBR solution, providing an opportunity for a wider portion of the pharmaceutical manufacturing industry to go paperless. The platform combines streamlined data capture and error prevention capabilities with a highly configurable, user-friendly modular design. This means that scaling to a paperless workflow is rapid while offering users the ability to modify manufacturing and quality control data processes to their specific requirements.
The workflow-driven data entry in the MODA™ Platform is also applicable to cleaning forms and capturing QC data, and the platform can be easily integrated with other GMP-compliant electronic systems and analytical equipment, allowing users to reliably transfer data across their manufacturing and quality-checking infrastructure.
The workshop, titled ‘Paper to EBR in Nine Months — How a Strong Collaboration Leads to Project Success’, will be delivered by Geoffrey Swafford, Senior Product Strategist at Lonza, and Bryan Beck, VP Information Technology at Nephron. The workshop will give delegates the opportunity to gain insight into how strong collaboration between vendor and customer can overcome the challenges and complexities of an EBR implementation at a small-to-medium sized company. More specifically, Lonza and Nephron will discuss:
- Nephron’s need for a cost-effective EBR solution to rapidly expand its 503b operations in response to increasing product demand
- Why Lonza’s MODA-ES™ Platform was the preferred EBR option for Nephron
- How Lonza partnered with Nephron to coordinate the parallel development and implementation of the MODA-ES™ Platform, delivering against an aggressive nine-month timeline
- How project risks were identified, managed and turned into successes through a solid vendor-customer partnership
- How the MODA-ES™ Platform helped to significantly increase Nephron’s operational efficiency and enabled its product line to expand from 25 to 75 different products
Geoffrey Swafford, Senior Product Strategist, Lonza:
Pharmaceutical manufacturers are increasingly turning to electronic batch record solutions to overcome the inherent inefficiencies of paper-based workflows. Nephron was one such company, looking for an affordable, flexible platform and a partner with the expertise to implement a solution to a very ambitious timeline. Lonza partnered with Nephron to simultaneously develop and implement the MODA-ES™ Platform in just nine months, and the resultant efficiency gains facilitated a significant expansion of Nephron’s 503b manufacturing operations."
Bryan Beck, VP Information Technology, Nephron Pharmaceuticals:
Recording a wealth of batch and quality data on paper had become a significant bottleneck in our attempts to react rapidly to market product shortages and to expand our manufacturing operations. However, we found most EBR solutions on the market didn’t meet our needs, particularly in terms of cost, flexibility and configurability. We wanted the ability to modify EBR workflows to accommodate our changing manufacturing processes without having to start from scratch each time or re-engage with suppliers, and we needed this rapidly — Lonza’s expertise and the MODA-ES™ Platform allowed us to do this."
Visitors can find out more about the MODA-ES™ Platform by speaking to one of Lonza’s experts at booth 138 at the 2019 ISPE Meeting & Expo, 27–30 October, or by visiting www.lonza.com/moda-es
Why Primary Cells Are Important for In Vitro ADME-Tox Studies